Table 2.
Key examples of ICPI FDA companion diagnostic approvals.
| IPCI | Drug class | PD-L1 antibody companion diagnostic | FDA licensed indications | Detection on immune cells/tumour cells | Study references |
|---|---|---|---|---|---|
| Pembrolizumab | PD-1 inhibitor | 22C3 (DAKO) | NSCLC first line | TPS ⩾ 50% | Reck et al.31 |
| NSCLC ⩾ second line | TPS ⩾ 1% | Herbst et al.32 | |||
| Metastatic OGJ/gastric cancer > second line | CPS ⩾ 1% | Fuchs et al.33 | |||
| Companion diagnostic not required in license but benefit shown in stated subpopulations | |||||
| Nivolumab | PD-1 inhibitor | 28-8 (DAKO) | NSCLC ⩾ second line | TC ⩾ 1% | Borghaei et al.34 |
| Atezolizumab | PD-L1 inhibitor | SP142 (Ventana) | NSCLC ⩾ second line | TC or TI ICs ⩾ 1% | Rittmeyer et al.35 |
| Urothelial cancer ⩾ second line or first line in those patients unfit for cisplatin | ⩾ 5% TI ICs | Powles et al.36 | |||
| Durvalumab | PD-L1 inhibitor | SP263 (Ventana) | Urothelial cancer ⩾ second line or first line in those patients unfit for cisplatin | IC > 1%: TC or IC ⩾ 25% or IC ⩽ 1%: TC ⩾ 25% or IC = 100% |
Powles et al.37 |
CPS = number of PD-L1 staining cells (tumour cells, lymphocytes, macrophages)/total cells × 100.
IC, immune cell; FDA, US Food and Drug Administration; NSCLC, non-small cell lung cancer; OGJ, oesophagogastric junction; PD-L1, programmed death ligand 1; TC, tumour cell; TI IC, tumour-infiltrating immune cell; TPS, tumour proportion score; CPS, combined proportion score.